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More articles about Regulatory News & FDA Approvals

Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.

While observers are still sorting out the implications of the surprise announcement, it will likely limit the agency's role in regulating LDTs.

The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.

Zymo Research said that the Quick SARS-CoV-2 rRT-PCR kit includes ready-to-use reaction mixtures that reduce hands-on time and eliminate human errors during the set-up process.

The firm had been distributing BGI's SARS-CoV-2 test kit but will stop distributing it effective immediately, OpGen's CEO said.

The firm said its genetic tests for breast, prostate, and colorectal cancers and melanoma assess a patient's personal cancer risks and guide personalized prevention.

The test is designed to detect the ORF1ab and nucleocapsid genes of the virus in upper respiratory specimens such as nasal swabs or nasal aspirates.

The firm can now tell customers if their genotypes may impact their response to clopidogrel and citalopram without the need for confirmatory testing.

The company received Emergency Use Authorization from the US Food and Drug Administration for another SARS-CoV-2 antibody test early last month.

The California-based genetic testing firm said its new lab will be able to process 20,000 tests per day and will initially focus on COVID-19 testing.

The test could be used in most high-complexity labs because it has been authorized for use with different combinations of frequently used reagents and instruments.  

The Pro-Lab Diagnostic Pro-AmpRT SARS-CoV-2 test consists of six primers and amplifies a 206 base-pair region of the ORF1ab gene of SARS-CoV-2.

Both tests can be run on standard PCR systems, while Biomeme's is also designed to run on the company's portable, handheld Franklin instrument.

The FDA letters were sent to two firms advertising an antibody home test being sold on two websites and a stool test for SARS-CoV-2.

The firm said its test will enable rapid, high-volume testing in schools, manufacturing facilities, hospitals, and care homes, among other settings.

Use of the two PCR-based tests is limited to their developers' CLIA-certified laboratories, according to the US Food and Drug Administration.

Use of the test, which detects viral nucleic acid in upper respiratory specimens and bronchoalveolar lavage, is limited to George Washington University.

The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.

The three tests are designed to detect antibodies, including immunoglobulin G and M, against SARS-CoV-2 in human serum and plasma.

The US Food and Drug Administration granted clearance to Diatron for an immunoassay that enables rapid screening for d-methamphetamine in human urine.

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